Blood collection and sampling apparatus provided with separable coupling means



ujan

2 Sheets-Sheet l v e Glenn Lofieafli filbert F. B

e. BEALL ET AL BLOOD COLLECTION AND SAMPLING APPARATUS PROVIDED WITH SEPARABLE COUPLING MEANS Nov. 16, 1965 Flled March 25 1965 Nov. 16, 1965 G. BEALL ETAL 3,217,710

BLOOD COLLECTION AND SAMPLING APPARATUS PROVIDED WITH SEPARABLE COUPLING MEANS Filed March 25, 1965 2 Sheets-Sheet 2 INVENTORS Ufenm oi eag BY Jfez ffagkve a i'fmmgg ll itcd States Patent 3,217,710 BLOQD COLLECTION AND SAMPLING APPA- RATUS PROVIDED WITH SEPARABLE COU- PLlNG MEANS Glenn L. Beall, Wildwood, and Albert F. Bnjan, Waukegan, Ill., assignors to Abbott Laboratories, North Chicago, 11]., a corporation of Illinois Filed Mar. 25, 1963, Ser. No. 267,752 1 Claim. (Cl. 128-214) This application is a continuation-in-part of application Serial No. 151,049, filed November 8, 1961, now abandoned.

This invention relates to an apparatus for collecting and sampling blood. In particular the apparatus of the invention provides a construction which is employa'ble to collect blood and then conveniently to enable a sampling of blood to be obtained.

It is generally the practice to obtain one or more samples of blood in the collection of blood for example for cross-matching and other purposes prior to its administration. The practice has been to provide an apparatus which includes a blood collecting container, an intravenous needle, and tubing providing communication between the intravenous needle and the blood collecting container. When the blood collecting container takes the form of a bottle, the tubing is ordinarily disconnected therefrom when the blood collecting container has been filled to the desired degree, and relatively small quantities of blood are bled from the donor into sampling pilot tubes. When the blood collecting containers takes the form of a blood bag, the tubing is severed with a scissors intermediate its ends. The severed portion of the tubing which leads from the intravenous needle is then inserted into a sampling pilot tube to obtain a sample from the donor.

The sampling device of the invention is disposed along tubing in a blood collecting and sampling apparatus having a blood collecting container, an intravenous needle, and tubing providing communication between the intraveous needle and the blood collecting container. The sampling device, during the collection of the blood, serves as a connector between one tube which leads from the intravenous needle and another tube which leads to the blood collecting container. When the blood collecting container has been filled to the desired degree, the tube between the sampling device of the invention and the blood collecting container is knotted, heat sealed, or clamped with a ferrule and the tube is disconnected from the hub portion of the sampling device. The sampling device is preferably provided with a cannula which is inserted into a sampling pilot tube to obtain a sample. The cannula is preferably provided with a pointed end so that a rubber stopper on the sampling pilot tube can be easily pierced.

It is of prime importance that the collected blood be maintained in a sterile condition and that the samples of the blood be sterile. Therefore, until the cannula of the blood sampling device is ready to be employed in its sampling capacity, it is maintained sterile by being sealed from ambient conditions.

The sampling device includes a hub portion and a freelength portion preferably joined by a rupturable portion. It is apparent that since the cannula is dis osed in an opening which extends from the hub portion, across the rupturable portion and into the free-length portion the cannula is completely sealed from contamination.

It is preferred to provide a rupturable portion so that the free-length portion can be easily removed to expose a free-length of the cannula.

In the diagrammatic drawings:

FIGURE 1 is a diagrammatic view showing the blood collecting and sampling apparatus employing the sampling device of the invention;

FIGURE 2 is a cross-sectional view of the sampling device of the invention taken along line 22 of FIG- URE 1;

FIGURE 3 is a cross-sectional view similar to that shown in FIGURE 2 but showing the free-length portion removed;

FIGURE 4 is a cross-sectional fragmentary view through a mold of an injection molding machine wherein the sampling device of the invention is molded;

FIGURE 5 is a perspective view showing the manner in which a sample of blood is collected into a sampling pilot tube;

FIGURE 6 is a partly cutaway elevational view of another embodiment of the sampling device of the invention;

FIGURE 7 is an enlarged cross-sectional view showing in detail the embodiment of the invention shown in FIG- URE 6 of the illustrative drawings;

FIGURE 8 is a cross-sectional view taken along line 8-8 of FIGURE 7;

FIGURE 9 is a fragmentary view, mainly in crosssection, showing still another embodiment of the sam pling device of the invention; and

FIGURE 10 is a cross-sectional view taken along line 1010 of FIGURE 9.

Referring now to the embodiment of FIGURES 1 through 5 of the illustrative drawings, there is shown a blood collecting and sampling apparatus generally indicated at 9 which includes a blood collecting container 10 into which blood from the donor is passed. The container 10 is provided with an elongated slot 11 through which a supporting member (not shown) can extend to support the container 10. A lower port-ion 12 of the container 10 is provided with a centrally disposed passage 13 to which a flexible tube 14 is connected for communication with the interior of the container 10. A ball 15 in the passage 13 prevents an anti-coagulant normally contained in the container 10 from escaping into the tube 14. The ball 15 is forced into the container 10 prior to the collect-ion of the blood so that blood can flow thereinto. I

The container 10 is shown to 'be provided with fittings 17 and 18. The blood collecting container 10 preferably takes the form of what is shown to be a bag composed of plasticized polyvinyl chloride; however, the invention is not dependent upon any particular type of blood collecting container.

A sampling device generally indicated at 20 includes a hub assembly 21 having a cannula 22 which is disposed in a longitudinally extending opening 23 therethrough. The hub assembly 21 includes a hub portion 24 and a freelength portion 25 joined by a tubular weakened or rupturable portion 26. The cannula 22 is shown to extend from the hub portion 24 across the rupturable portion 26 and into the free-length portion 25. One end of the cannula 22 is shown to be flared at 27 so as to be keyed into the hub portion 24. Although the one end of the cannula 22 is shown to be flared for purposes of keying, any suitable means as for example projections or the like extending radially outwardly from the periphery of the cana nula, suitable for keying the cannula and the hub portion 24 is employable. The rupturable portion 26 is shown to be of lesser diameter than the diameter of either the freelength portion 25 or the hub portion 24 so that when opposed finger grips 28 and 29 which project outwardly from the free-length portion 25 are grasped, the rupturable por tion 26 is easily ruptured. Although the finger grips 28 and 29 are provided as the preferred form of gripping means, in an alternative construction (not shown) the free-length portion 25 can be enlarged in the place where the finger grips 28 and 29 appear and the outer surface thereof can be roughened for example by knurling.

The marginal end of the hub portion 24 is provided with continuous circumferentially extending barbs 30 and 31 which face the free-length portion 25, while the freelength portion 25 is provided with continuous circumferentially extending barbs 32 and 33 which face the hub portion 24.

A shield 38 of the free-length portion 25 extends beyond a pointed end 39 of the cannula 22 in order to prevent the pointed end 39 from piercing the tube 14. One end of a flexible tube 14' is received externally onto the hub portion 24 and is secured and gripped by the barbs 31 and 32, while the tube 14 is received externally by the marginal end of the free-length portion 24 and is secured and gripped by barbs 32 and 33. The other end of the tube 14' is connected to an intravenous needle 35 of conventional construction. A hood 36 is provided to fit over a cannula 37 of the intravenous needle 35. The term tubing generally indicated at 19 includes the tube 14, the tube 14 and the sampling device 20 during the collection of the blood.

The rupturable portion 26 is shown to have been severed and the free-length portion 25 is shown to have been removed from the cannula 22 in FIGURE 3 of the illustrative drawings. After the blood collecting container has been filled to the desired degree, a free-length 22 of the cannula 22 is inserted into a sampling pilot tube T through a rubber stopper S as shown in FIGURE of the illustrative drawings, or into an open-ended sampling pilot tube from which the rubber stopper has been removed.

Referring now to FIGURE 4 of the illustrative drawings, there is shown a fragmentary portion of a mold generally indicated at 40. A main core pin 41 is secured n a mold cavity 42 in the mold 40. The main core pin 41 serves both to form the opening 23 in the hub assembly 21 and to support the cannula 22 in its proper position while the hub assembly 21 is molded. The molding material is passed into a sprue 43, through a runner 44, and into the mold cavity 42. The terminal end of the free-length portion 25 is formed by a core pin retainer 45 which in addition serves to maintain a terminal end 46 of the main core pin in position. It is apparent that the cannula is keyed directly into the hub portion 24 by the flared portion 27 of the cannula 22.

The hub assembly 21 is preferably composed of a plastic material and in particular a moldably nylon and the cannula 22 is preferably composed of steel in particular stainless steel. Nylon has the advantage that when the nylon comes in contact with water or water vapor, the nylon tends to expand. Water is absorbed by the nylon during for example sterilization of the apparatus of the invention. Since the apparatus of the invention is packaged in a water and vapor tight enclosure and since the blood collecting container transmits small quantities of water therethrough until a condition of equilibrium is achieved, the nylon hub assembly 21 also takes on moisture in this manner. The expansion of the nylon hub assembly 21 permits the free-length portion 25 to be readily removed after the rupturable portion 26 is ruptured, while at the same time the cannula 22 is keyed into the hub portion 24. Since the cannula 22 is keyed into the hub portion 24, there can be no sliding in either longitudinal direction of the cannula 22 within the bore 23 of the hub portion 24. The hub assembly 21 can be composed of 4; materials of construction other than nylon which have the same property of expandability. Alternatively, the hub assembly 21 can be composed of a material which need not be expandable, in which case the free-length 22 of the cannula 22 can be coated with a material or treated in such a way so that the free-length portion 25 does not adhere to the free-length 22 of the cannula 22. It is to be understood, of course, that other materials for constructing the hub assembly 21 are employable, for example rubber modified styrene known as an ABS polymer and sold commercially under each of the trademarks Kralastic and Cycolac. This polymer is solvent scalable to the tubes 14 and 14', which are preferably composed of polyvinyl chloride, and is autoclavable at normal temperatures and pressure, and is expandable since it takes on water or water vapor but to a lesser extent than nylon.

In regard to the method of use, the hood 36 is removed from the cannula 37 which is inserted into the donor in order to collect the blood. The blood flows gravitationally through the tube 14', through opening 23 which contains the cannula 22, into the tube 14, and into the blood collecting container 10. When the blood collecting container 10 has been filled to the desired degree, the tube 14 is knotted or sealed in some conventional manner, and the tube 14' is clamped with a hemostat. The free-length portion 25 is then rotated relative to the hub portion 24 to rupture the rupturable portion 26 whereupon the freelength portion 25 is slidably removed from the free-length 22 of the cannula 22. The free-length 22) of the cannula 22 is then inserted into a sampling pilot tube and the hemotat is removed in order to collect a blood sample. Other samples are obtainable by reclamping the tube 14' with the hemostat, withdrawing the free-length 22 of the cannula 22 from the preceding sampling pilot tube, inserting the free-length of the cannula into the next sampling pilot tube, and then removing the hemostat, and so on. Then the tube 14 is again clamped with a hemostat and the cannula 37 is removed from the donor.

In the embodiment of FIGURES 6 through 8 of the illustrative drawings, the same reference characters are employed to designate those components having the same construction, function and relative location as in the embodiment of FIGURES 1 through 5 of the illustrative drawings, with the addition of the reference character a. With reference to the embodiment of FIGURES 6 through 8 of the illustrative drawings, there is shown a sampling device generally indicated at 20a including a hub assembly 21a and a cannula 22a which is disposed in an opening 23a therethrough. The hub assembly 21a includes a hub portion 24a and a free-length portion 25a joined by a weakened or rupturable portion generally indicated at 26a. The rupturable portion 26a is shown to include four spaced webs 50, 51, 52, and 53 which are shown to be disposed at right angles to each other. Although four webs are shown in the drawings a lesser number, for example at least one, is employable The advantage of providing one or more webs, as in the embodiment of FIG- URES 6 through 8, rather than a continuous annular rupturable portion, as in the embodiment of FIGURES 1 through 5, is that with the former, dimensional consistency is more easily achieved during molding than with the latter. Dimensional consistency is desired because the rupturing torque required to rupture the rupturable por tion will otherwise vary. The webs 50 through 53 are shown to connect the hub portion 24a and the free-length portion 25a. The webs 50 through 53 are shown to be in abutment with the outer surface of the cannula 22a and are shown to extend in a radially outward direction and to taper to relatively sharp, pointed edges 50, 51, 52' and 53', respectively. The cannula 22a is shown to extend from the hub portion 24a across the rupturable portion 26a and into the free-length portion 25a. One end of the cannula 22a is shown to be flared at 27a so as to be keyed into the hub portion 24a. The free-length portion 25a is shown to have opposed finger grips 28a and 29a which 3 project outwardlyin opposed directions, although other means for facilitating gripping are obviously within the scope of the invention. The free-length portion 25a encloses the free-length 22fa of the cannula'25a.

The marginal end of the hub portion 24a is shown to be provided with spaced continuous, circumferentially extending barbs 30a and 31a which face the free-length portion 25a, while the free-length portion 25a is shown to be provided with spaced continuous, circumferentially extending barbs 32a and 33a which face the hub portion 24a.

The free-length portion 25a extends beyond a pointed end 39a of the cannula 22a to form a shield 380 which prevents the pointed end 39a from piercing a flexible tube 14a. A marginal end of the flexible tube 14a is received externally onto the hub portion 24a and is secured and gripped by the barbs 30a and 31a, while a marginal end of the tube 14a is received externally by the free-length portion 25a and is secured and gripped by the barbs 32a and 33a.

Since the rupturable portion 26a is not continuous and annular in extent as the rupturable portion 26 shown in the embodiment of FIGURES 1 through 4 of the illustrative drawings, a continuous seal generally indicated at 54 is preferably provided. The seal 54 assures the maintenance of sterility of the free-length 22fa of the cannula 22a by sealing ofl an exposed portion 22x of the cannula 22a from contamination. The seal 54 bridges the rupturable portion 26a and is received by a continuous annular end 55 of the hub portion 24a and by a continuous annular end 56 of the free-length portion 25a. The end 56 is shown to have a continuous annular barb 57 which faces away from the hub portion 24a. The seal 54 specifically takes the form of a resilient band which is preferably composed of rubber.

Disposed between the barbs 30a and 31a is a resilient band 58, composed for example of rubber, which serves to hold a marginal end 59 of the tube 14a in hoop compression against the hub portion 24a. The resilient band 58 thereby serves to prevent the tube 114a from slipping ofl? the hub portion 24a. The resilient band 58 is preferably relatively wide in relation to the spacing of the barbs 30a and 31a and the barbs 30a and 31a are spaced relatively close to each other, as shown. Normally, the portion 60 of the marginal end 59 of the tube 14a spans the barbs 30a and 31a and would have an hour-glass shape. The resilient band 58, however, stretches the position 60 and holds it against the hub portion 24a. Disposed between the barbs 32a and 33a is a resilient band 61, composed for example of rubber, which serves to hold a marginal end 62 of the tube 14a in hoop compression against the free-length portion 25a. The resilient band 61 thereby serves to prevent the tube 14a from slipping off the free-length portion 25a. The band 61 is preferably relatively wide in relation to the spacing of the barbs 32a and 33a and the barbs 32a and 33a are spaced relatively close to each other, as shown. Normally, the portion 63 of the marginal end 62 of the tube 14a spans the barbs 32a and 33a and would have an hour-glass shape. The resilient band 61, however, stretches the portion 63 and holds it against the free-length portion 25a.

The embodiment of FIGURES 9 and of the illustrative drawings is almost identical with the embodiment of FIGURES 6 through 8 of the illustrative drawings and, therefore, the same reference characters are employed to designate those components having the same construction, function and relative location as in the embodiment of FIGURES 6 through 8 of the illustrative drawings with the exception of the reference character b which is employed instead of the reference character a. In the embodiment of FIGURES 9 and 10 of the illustrative drawings, there is shown a sampling device generally indicated at 20b which includes a hub assembly 21b having a cannular 22b disposed in an opening 23b therethrough. The hub assembly 21b includes a hub portion 24b and a 6 free-length portion'25b joined by a weakened or rupturable portion generally indicated at 26b. Gripping means in the form of finger grips 28b and 29b are shown to extend outwardly from the free-length portion 25b in opposite directions. A tube 14b is shown to be received externally by the free-length portion 25b.

One difference between the embodiment of FIGURES 9 and 10 in relation to the embodiment of FIGURES 6 through 8 is that the rupturable portion 26b is shown to include a continuous annular film-like tubular portion 70 from which there extend four spaced webs 71, 72, 73 and 74 in a radially outward direction and at right angles with respect to each other. The webs 71 through 74 taper outwardly to relatively sharp, pointed edges 71', 72', 73' and 74, respectively. The tubular portion 70 and webs 71 through 74 connect the hub portion 24b and the free-length portion 25b.

The only other difference is that no seal, such as the seal 54, is required since the tubular portion 70 maintains the sterility of the cannula 22b.

The description of the method of use of the embodiment of FIGURE 1 through 5 o fthe illustrative drawings applies equally well to the embodiment of FIGURES 6 through 8 and the embodiment of FIGURES 9 and 10 and therefore need not be repeated. The same materials are readily employable in the embodiment of FIGURES 6 through 8 and the embodiment of FIGURES 9 and 10 as are disclosed with regard to the embodiment of FIG- URES 1 through 5.

The above-described embodiments being exemplary only, it will be understood that modifications in form or detail from the presently described embodiments can be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be considered as limited save as is consonant with the scope of the following claim.

What is claimed is:

An apparatus for collecting and sampling blood comprising: a blood collecting container, an intravenous needle, a first length of tubing having an end in communication with said container, a second length of tubing having an end in communication with said needle, a unitary, rigid, plastic hub assembly defining an axial passage extending therethrough and a peripherally weakened portion separating said hub assembly into a lower section and an upper section, a cannula disposed in said passage and having a flared end molded into said lower section and a pointed end portion extending into said upper section terminating inboard the end face thereof and slidable therein when said two sections are separated, at least one circumferentially extending barb formed proximate either outer end of said hub assembly, the free end of said first length of tubing overlying and frictionally engaging the end of the upper section of said hub assembly and said barb thereon, the free end of said second length of tubing overlying and frictionally engaging the end of the lower section and said barb thereon, and a pair of integral opposingly disposed wing members on said removable upper section, whereby an uninterrupted, sealed flow path is initially formed between said container and said needle, and said cannula point may be exposed by rotation of said wing members with respect to said hub section to enable said cannula point to be introduced into a sampling tube and providing a tamper indication at said line of weakness.

References Cited by the Examiner UNITED STATES PATENTS 2,674,265 4/1954 Dennis 137-610 2,836,942 6/ 1958 Miskel 12822l X 2,894,510 7/1959 Bellamy 128-272 3,073,307 1/1963 Stevens 128-221 3,127,892 4/1964 Bellamy et al. 128-214 (Other references on following page) 3,217,710 7 E23 FOREIGN PATENTS Equipment, Jo. Lab. & Clinical Med., February 1954, 1,082,035 6/1954 France. 1215732 11/1959 France- RICHARD A. GAUDET, Primary Examiner.

OTHER REFERENCES 5 ROBERT E. MORGAN, Examiner. Gardner et al.: Platelet Transfusions Utilizing Plastic 

